Archive for November, 2013

(OREX) to Present at the 25th Annual Piper Jaffray Healthcare Conference

SAN DIEGO, Nov. 27, 2013  — Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will present a company overview at the 25th Annual Piper Jaffray Healthcare Conference in New York. The presentation is scheduled for Tuesday, December 3rd  at 11:00 a.m. Eastern Time. To listen to the live webcast or a replay of the presentation, please visit the Investor Relations section of the Company’s Web site at www.orexigen.com. A replay will be available for 14 days after the event.

About Orexigen® Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company’s lead product candidate is Contrave, which the Company is evaluating in the Light Study, a cardiovascular outcomes trial being conducted under a Special Protocol Assessment (SPA) with the FDA. Based on successful results of the Light Study, the Company plans to resubmit the Contrave NDA to the FDA with potential approval by June 2014.The Company’s other product candidate, Empatic, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.

Orexigen Contact: Media Contact:
McDavid Stilwell Denise Powell
VP, Corporate Communications and Business Development BrewLife
(858) 875-8629 (510) 703-9491
Wednesday, November 27th, 2013 Uncategorized Comments Off on (OREX) to Present at the 25th Annual Piper Jaffray Healthcare Conference

(INBK) Closing of Upsized Public Offering, Exercise of Over-Allotment Option

First Internet Bancorp (NASDAQ: INBK), the parent company of First Internet Bank of Indiana (the “Bank”), today announced the closing of its underwritten public offering of 1,587,000 shares of its common stock, including 207,000 shares issued pursuant to the underwriters’ 30-day option, at a price to the public of $20.00 per share. The net proceeds of the Company after deducting underwriting discounts and commissions and estimated offering expenses are expected to be approximately $29.1 million.

Sandler O’Neill + Partners, L.P. served as sole book-running manager of the offering, and Keefe, Bruyette & Woods, Inc. acted as co-manager. Faegre Baker Daniels LLP served as legal counsel to the Company. Patton Boggs LLP served as legal counsel to the underwriters.

A registration statement relating to these securities has been filed with, and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale of securities would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The offering was made only by means of a prospectus, copies of which may be obtained from Sandler O’Neill + Partners, L.P., 1251 Avenue of the Americas, 6th Floor, New York, NY 10020, (866) 805-4128. The registration statement may also be accessed through the SEC’s website.

First Internet Bancorp

First Internet Bancorp (NASDAQ: INBK) is the parent company of First Internet Bank of Indiana (www.firstib.com), a premier provider of online retail and business banking services nationwide. First Internet Bank opened for business in 1999. The Bancorp became the parent of the Bank effective March 21, 2006.

About First Internet Bank of Indiana

First Internet Bank of Indiana is the first state-chartered, FDIC-insured institution to operate solely via the Internet and has customers in all 50 states. Deposit services include checking accounts, regular and money market savings accounts, CDs and IRAs. First Internet Bank also offers consumer loans, conforming mortgages, jumbo mortgages, home equity loans and lines of credit, and commercial loans. This year, First Internet Bank was named one of the Best Places to Work in Indiana by the Indiana Chamber of Commerce, one of the Best Banks to Work For by American Banker Magazine, and the top Online Originator by Mortgage Technology. The Bank is a wholly owned subsidiary of First Internet Bancorp.

Wednesday, November 27th, 2013 Uncategorized Comments Off on (INBK) Closing of Upsized Public Offering, Exercise of Over-Allotment Option

(PEIX) to Present at the LD Micro Conference on December 3, 2013

SACRAMENTO, Calif., Nov. 27, 2013  — Pacific Ethanol, Inc. (Nasdaq:PEIX), the leading marketer and producer of low-carbon renewable fuels in the Western United States, announced management will present at the LD Micro Conference at the Luxe Sunset Bel Air Hotel in Los Angeles on Tuesday, December 3, 2013 at 11:30 a.m. Pacific Time.

A live audio webcast of the company’s presentation will be available on the investor relations section of the company’s website at www.pacificethanol.net starting at approximately 11:30 a.m. Pacific Time/2:30 p.m. Eastern Time on Tuesday, December 3, 2013.

About Pacific Ethanol, Inc.

Pacific Ethanol, Inc. (Nasdaq:PEIX) is the leading marketer and producer of low-carbon renewable fuels in the Western United States. Pacific Ethanol also sells co-products, including wet distillers grain (“WDG”), a nutritious animal feed. Serving integrated oil companies and gasoline marketers who blend ethanol into gasoline, Pacific Ethanol provides transportation, storage and delivery of ethanol through third-party service providers in the Western United States, primarily in California, Arizona, Nevada, Utah, Oregon, Colorado, Idaho and Washington. Pacific Ethanol has an 85% ownership interest in New PE Holdco LLC, the owner of four ethanol production facilities. Pacific Ethanol operates and manages the four ethanol production facilities, which have a combined annual production capacity of 200 million gallons. The facilities in operation are located in Boardman, Oregon, Burley, Idaho and Stockton, California, and one idled facility is located in Madera, California. The facilities are near their respective fuel and feed customers, offering significant timing, transportation cost and logistical advantages. Pacific Ethanol’s subsidiary, Kinergy Marketing LLC, markets ethanol from Pacific Ethanol’s managed plants and from other third-party production facilities, and another subsidiary, Pacific Ag. Products, LLC, markets WDG. For more information please visit www.pacificethanol.net.

CONTACT: Company IR Contact:
         Pacific Ethanol, Inc.
         916-403-2755
         866-508-4969
         Investorrelations@pacificethanol.net

         IR Agency Contact:
         Becky Herrick
         LHA
         415-433-3777

         Media Contact:
         Paul Koehler
         Pacific Ethanol, Inc.
         916-403-2790
         paulk@pacificethanol.net
Wednesday, November 27th, 2013 Uncategorized Comments Off on (PEIX) to Present at the LD Micro Conference on December 3, 2013

(LPDX) to Present at 25th Annual Piper Jaffray Healthcare Conference

RALEIGH, N.C., Nov. 27, 2013 — LipoScience, Inc. (Nasdaq:LPDX) today announced that Bob Greczyn, Interim President and Chief Executive Officer, and Lucy Martindale, Executive Vice President and Chief Financial Officer, will present at the 25th Annual Piper Jaffray Healthcare Conference at 11:00 A.M. ET on Wednesday, December 4, 2013, in New York City.

The presentation will be webcast live and can be accessed on the Investor Relations section of the corporate website at http://investor.liposcience.com. For those who are not available to listen to the live broadcast, the webcast will be archived for 90 days.

About LipoScience, Inc.

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. The company’s first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low-density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 10 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera®, has been cleared by the U.S. Food and Drug Administration (FDA). It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology through ease of use and walk-away automation. The Vantera Clinical Analyzer will be placed with national and regional clinical laboratories.

LipoScience is striving toward the NMR LipoProfile test becoming the preferred choice by physicians for management of cardiovascular disease. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

CONTACT: Investor Relations
         ICR, Inc.
         Bob Yedid
         Senior Vice President
         646-277-1250
         bob.yedid@icrinc.com

         LipoScience, Inc.
         Tori Hall
         tori.hall@liposcience.com
         (919) 256-1046
Wednesday, November 27th, 2013 Uncategorized Comments Off on (LPDX) to Present at 25th Annual Piper Jaffray Healthcare Conference

(AZC) Announces Completion and Availability of Rosemont Final EIS

TORONTO, Nov. 27, 2013  – Augusta Resource Corporation (TSX/NYSE MKT: AZC) (“Augusta” or “the Company”) is pleased to announce the US Forest Service (USFS) has publicized that they have completed the Rosemont Copper final Environmental Impact Statement (EIS) and the complete document will be posted on the USFS Rosemont project website beginning November 29, 2013.

“The publication of the Final EIS is the culmination of over six years of comprehensive environmental and technical studies and analyses,” said Gil Clausen, Augusta’s President and CEO. “This is an exciting and significant achievement for the Company.  We are pleased that the U.S. Forest Service has completed the document and sincerely thank the team and all parties involved for their diligence and efforts. With the EIS process concluded, we can move forward and finalize the last remaining steps of permitting.”

The final EIS and draft Record of Decision (ROD) have been sent for printing and the USFS expects the official Notice of Availability (NOA) for the FEIS to be published in the Federal Register along with the draft ROD to be available on December 13, 2013. Upon public and legal notification on December 15, 2013, the 90-120 day comment and resolution period for the draft ROD commences, following which a final ROD will be issued.

ABOUT AUGUSTA
Augusta is a base metals company focused on advancing the Rosemont Copper deposit near Tucson, Arizona. Rosemont hosts a large copper/molybdenum reserve that would account for about 10% of US copper output once in production (for details refer to www.augustaresource.com). The exceptional experience and strength of Augusta’s management team, combined with the developed infrastructure and robust economics of the Rosemont project, propels Augusta to becoming a solid mid-tier copper producer. The Company trades on the Toronto Stock Exchange and the NYSE MKT under the symbol AZC.

CAUTIONARY STATEMENTS REGARDING FORWARD LOOKING INFORMATION

Certain of the statements made and information contained herein may contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws. Such forward-looking statements and forward-looking information include, but are not limited to statements concerning: expectations surrounding, short term financing, future project financings or refinancing; the Company’s plans at the Rosemont Project including timing for final permits and construction; estimated production; and capital and operating and cash flow estimates. Forward-looking statements or information include statements regarding the expectations and beliefs of management. Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or the negatives thereof or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved.

Forward-looking statements or information are subject to a variety of risks and uncertainties which could cause actual events or results to differ from those reflected in the forward-looking statements or information, including, without limitation, risks and uncertainties relating to: history of losses; requirements for additional capital; dilution; loss of its material properties; interest rates increase; global economy; no history of production; speculative nature of exploration activities; periodic interruptions to exploration, development and mining activities; environmental hazards and liability; industrial accidents; failure of processing and mining equipment; labour disputes; supply problems; commodity price fluctuations; uncertainty of production and cost estimates; the interpretation of drill results and the estimation of mineral resources and reserves; legal and regulatory proceedings and community actions; title matters; regulatory restrictions; permitting and licensing; volatility of the market price of Common Shares; insurance; competition; hedging activities; currency fluctuations; loss of key employees; as well as those factors discussed in the section entitled “Risk Factors” in the Company’s Annual Information Form dated March 25, 2013. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information. The Company disclaims any intent or obligation to update forward-looking statements or information except as required by law, and you are referred to the full discussion of the Company’s business contained in the Company’s reports filed with the securities regulatory authorities in Canada and the United States.

SOURCE Augusta Resource Corporation

Augusta Resource Corporation
Letitia Cornacchia, Vice President,
Investor Relations and Corporate Communications
Tel: (416) 860 6310
Email: lcornacchia@augustaresource.com

Wednesday, November 27th, 2013 Uncategorized Comments Off on (AZC) Announces Completion and Availability of Rosemont Final EIS

(SMSI) Regains Compliance With NASDAQ Minimum Bid Price Rule

ALISO VIEJO, CA–(Nov 26, 2013) – Smith Micro Software, Inc. (NASDAQ: SMSI) today announced that it has received notice from the NASDAQ stock market (“NASDAQ”) that the Company has regained compliance with the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market.

As previously reported, NASDAQ notified the Company on November 7, 2013 that the bid price of the Company’s common stock had closed below the minimum $1.00 per share requirement over the previous 30 consecutive business days and, as a result, the Company was not in compliance with Listing Rule 5450(a)(1). On November 25, 2013, NASDAQ notified the Company that the closing bid price of its common stock has been at $1.00 per share or greater for at least 10 consecutive business days. Accordingly, NASDAQ has confirmed to the Company that it has regained compliance with the minimum bid price rule and the matter is now closed.

“As mentioned during our last earnings call, we’ve made great strides to right-size our expense structure while refining our product and go-to-market strategies to bring new revenue streams to bear,” said William W. Smith, Jr., President and CEO of Smith Micro Software. “I’m confident that our hard work will pay off in 2014, and we look forward to a more stable and profitable year that should build on improved revenue growth in Q4 of this year.”

About Smith Micro Software, Inc.:
Smith Micro Software provides solutions that simplify, secure and enhance the mobile experience. Our portfolio includes a wide range of applications that manage broadband connectivity, data traffic, devices, voice and video communications over wireless networks. With 30 years of experience developing world-class client and server software, Smith Micro helps the leading mobile network operators, device manufacturers and enterprises increase efficiency and capitalize on the growth of mobile-connected consumers and workforces. For more information, visit smithmicro.com. (NASDAQ: SMSI)

Smith Micro and the Smith Micro logo are registered trademarks or trademarks of Smith Micro Software, Inc. All other trademarks and product names are the property of their respective companies.

Contacts:

Investor Relations:

Todd Kehrli or Jim Byers
MKR Group, Inc.
323-468-2300
Email Contact

Public Relations:

Suzanne Runald
949-362-5800
Email Contact

Tuesday, November 26th, 2013 Uncategorized Comments Off on (SMSI) Regains Compliance With NASDAQ Minimum Bid Price Rule

(UBIC) Masami Yaguchi Named CFO, CAO

Former CFO and CAO, Seitaro Ishii, Transitions to Senior Strategic Advisor

TOKYO, Nov. 26, 2013 — UBIC, Inc. (Nasdaq:UBIC) (TSE:2158), a leading provider of Asian-language eDiscovery solutions and services, today announced that Masami Yaguchi, currently the company’s Controller, will assume the joint position of Chief Financial Officer (CFO) and Chief Administrative Officer (CAO), effective Dec. 1.

Mr. Yaguchi replaces Seitaro Ishii as CFO and CAO who, after assisting in expanding the company’s presence in Asia, North America and Europe and helping to guide it through a successful listing on the Nasdaq Stock Market, will decrease his day-to-day responsibilities to spend more time with his family. A member of UBIC’s senior management team since he joined the company in 2010, Mr. Ishii will continue as a strategic advisor to Chief Executive Officer Masahiro Morimoto and Mr. Yaguchi. He will also remain a member of the board of directors of UBIC’s North American subsidiary.

“It has been my pleasure to work closely with Sam Ishii over the past four years. His leadership and experience were invaluable as the company grew its business and technology, and expanded its presence around the globe,” Mr. Morimoto said. “I am grateful for his help and I am happy Sam will continue as a strategic advisor to me and the senior management team at UBIC.

“UBIC’s new CFO and CAO, Masami Yaguchi, is a talented financial professional. He has demonstrated tremendous capability as Corporate Controller working with our management team over the past year,” Mr. Morimoto said. “His talent, his accomplishments and his familiarity with UBIC make Yaguchi-san a natural choice to succeed Sam Ishii in these key senior management roles.”

Prior to joining UBIC in December, 2012, Masami Yaguchi, 52, served in a variety of management positions in finance and administration including CFO and CAO of a start-up company Springsoft, Inc.; and Finance and Accounting Director for CMA CGM Japan, a world leader in container shipping. He has also worked in various finance roles including operations controller and treasury and tax for Applied Materials Japan, one of the world’s top semiconductor equipment companies.

About UBIC

UBIC, Inc. (TSE:2158) (Nasdaq:UBIC) is a leading provider of Asian-language eDiscovery, forensic solutions and services. UBIC has extensive eDiscovery and forensic experience and expertise with information documented in Japanese, Korean, Chinese as well as English languages, and applies its expertise in connection with cross-border litigation, administrative proceedings and internal investigations, including those related to anti-trust investigations, intellectual property (IP) litigation, the Foreign Corrupt Practices Act (FCPA) and product liability (PL) investigations.

UBIC serves its clients from offices in Japan, the United States, South Korea, Taiwan, Hong Kong and the United Kingdom. UBIC’s proprietary technology platform, Lit i View™, version 6.7, is an innovative eDiscovery solution that accurately handles Asian-language characters, encoding schemes and native file systems. UBIC also recently launched its flexible and customizable Legal Cloud™ service to address the problem of rising costs associated with the growth and dispersion of data volumes across the globe, along with prolonged investigations and litigations.

With flexible, customizable end-to-end solutions and services covering the entire electronic discovery reference model (EDRM) life-cycle for corporate litigation strategy and crisis management, UBIC has assisted clients in more than 310 administrative and legal proceedings in the United States, including Department of Justice (DOJ), International Trade Commission (ITC) and Securities and Exchange Commission (SEC) investigations and more than 700 corporate investigations in Japan, South Korea, China, Taiwan and Singapore. Assisted by highly experienced litigation attorneys, UBIC provides a range of services facilitating fact discovery, patent management, security, internal audit and regulatory compliance that can provide a significant cost savings to its clients.

For more information about UBIC, contact info@ubicna.com or visit http://www.ubicna.com

Safe Harbor Statement

This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this announcement, as well as UBIC’s strategic and operational plans, contain forward-looking statements. UBIC may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about UBIC’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: UBIC’s goals and strategies; UBIC’s expansion plans; the expected growth of the data center services market; expectations regarding demand for, and market acceptance of, UBIC’s services; UBIC’s expectations regarding keeping and strengthening its relationships with customers; UBIC’s plans to invest in research and development to enhance its solution and service offerings; and general economic and business conditions in the regions where UBIC provides solutions and services. Further information regarding these and other risks is included in UBIC’s reports filed with, or furnished to the Securities and Exchange Commission. UBIC does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release and in the attachments is as of the date of this press release, and UBIC undertakes no duty to update such information, except as required under applicable law.

CONTACT: Investor Relations Contact:

         UBIC, Inc. (North America)
         Dan Charnas
         Tel: +1 646-308-1561
         Email: ir@ubicna.com

         ICR, Inc.
         Jeremy Peruski
         Tel: +1 646-308-1561
         Email: ir@ubicna.com
Tuesday, November 26th, 2013 Uncategorized Comments Off on (UBIC) Masami Yaguchi Named CFO, CAO

(ETAK) to Present at the Sixth Annual LD Micro Conference

OKLAHOMA CITY, Nov. 26, 2013  — Elephant Talk Communications Corp. (NYSE MKT: ETAK), (www.elephanttalk.com), a leading international provider of mobile proprietary Software Defined Network Architecture (Software DNA™) platforms and a market leader in providing cyber security solutions to counter electronic fraud in the cloud, today, announced that Mr. Steven van der Velden, Chief Executive Officer of the Company, will present at the Sixth Annual LD Micro Conference taking place on December 3-5, 2013 in Los Angeles, California.

Conference Presentation Details:
Where: Luxe Sunset Boulevard Hotel
11461 Sunset Blvd., Los Angeles, California 90049
When/Track: December 5th at 8:30 a.m. Pacific on Track 2
Conference Website: www.ldmicro.com

For those interested in a one-on-one meeting with management, please contact Chris Camarra at (212) 398-3487, or ccamarra@allianceadvisors.net.

About Elephant Talk:
Elephant Talk Communications Corp. (NYSE MKT: ETAK), is a leading international provider of mobile proprietary Software Defined Network Architecture (Software DNA™) platforms for the telecommunications industry that empower Mobile Network Operators (MNOs) and Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, Full OSS/BSS Systems, Delivery Platforms, Support and Managed Services, on-site, cloud, hybrid and S/PaaS solutions, including Network, Mobile Internet ID Solutions, Secure Remote Access Management, Loyalty Management and Transaction Processing Services, superior Industry Expertise and high quality Customer Service without substantial upfront investment. Elephant Talk counts several of the world’s leading Mobile Operators amongst its customers, including Vodafone, T-Mobile, Zain and Iusacell. Virtually all business is focused on tier 1 and tier 2 operators worldwide. Visit: www.elephanttalk.com.

Forward-Looking Statements
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to the Company’s plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about the Company’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of the Company may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, the Company also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from that projected or suggested is contained in the Company’s filings with the Securities and Exchange Commission (SEC), copies of which are available from the SEC or may be obtained upon request from the Company.

Media Contacts:

Investor Relations:
Steve Gersten
Elephant Talk Communications Corp.
+ 1 813 926 8920
steve.gersten@elephanttalk.com

Thomas Walsh
Alliance Advisors
+ 1 212 398 3486
twalsh@allianceadvisors.net

Public Relations:
US: Michael Glickman
MWG CO
(917) 596.1883
mike@mwco.net

Tuesday, November 26th, 2013 Uncategorized Comments Off on (ETAK) to Present at the Sixth Annual LD Micro Conference

(ECTE) Announces Positive CE Mark Regulatory Trial Results of Symphony® CGM System

Symphony meets primary safety and effectiveness endpoints Company on target to file CE Mark Technical File by year end

PHILADELPHIA, Nov. 26, 2013  — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced positive results from its multi-center clinical trial of the Symphony CGM System in surgical patients in hospital critical care units.  Data collected from this study will serve as the basis for the CE Mark Technical File submission for marketing approval in Europe, which the Company expects to submit in the fourth quarter of 2013.

Symphony met the primary safety and effectiveness endpoints of the trial which involved the continuous monitoring of glucose levels in 32 subjects in the critical care units at four investigational sites.  In the trial, Symphony monitored glucose levels with a mean absolute relative difference (MARD), or error rate, of 12.5%.  The Continuous Glucose-Error Grid Analysis (CG-EGA) showed that 97.9% of the readings were clinically accurate (A) and 1.8% were benign (B) errors with a combined A+B categorization of 99.7%.

“We are extremely pleased with the positive results of this trial. Importantly, this was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial. We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements,” said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics.  “We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes.”

Study Results

Using over 630 Symphony CGM glucose readings paired with reference blood glucose measurements in thirty-two (32) study subjects, CG-EGA showed that 97.9% of the readings were clinically accurate and 1.8% were benign errors, with a combined A+B value of 99.7%.  The MARD for the study was 12.5%.  There were no adverse events reported from the skin preparation or the Symphony CGM sensor session.  The range of glucose values was 49 – 324 mg/dL.

Trial Design

This trial was designed to evaluate the performance of Echo’s Symphony CGM System in thirty-two (32) post-surgical patients in the critical care setting at four investigational sites. Three enrolled patients who were administered an IV formulation of acetaminophen were subsequently excluded from the study based on an observed interference with the glucose sensor. The skin of each patient was prepared using the skin preparation device, and a Symphony CGM sensor was then applied to the prepared site.  During the 24-hour study period, a maximum of thirty reference blood samples were taken from arterial line catheters and measured on a YSI 2300 STAT Plus Glucose Analyzer as a reference.  The data collected by Symphony was blinded to study subjects and investigational institution clinical staff.  At the conclusion of the study period, the prepared skin sites were inspected for redness or other undesirable effects immediately following sensor removal, and again 7 days after sensor removal.

Analytical Methods

Continuous data from the Symphony CGM System were compared to reference measurements from the YSI 2300 STAT Plus Glucose Analyzer. Those reference measurements were paired with the Symphony results through a data analysis algorithm. Data from the three subjects with the observed IV acetaminophen interference were excluded from the analysis, as these subjects were not considered evaluable due to the interference issue. The primary statistical analytical tools used to evaluate the performance of Symphony were MARD and CG-EGA. Numerical accuracy is measured using MARD, an error calculation tool that was used to measure the absolute value of the average relative difference between Symphony and the reference measurements, on a percentage basis. The CG-EGA is a categorization of all data pairs based on the clinical significance of the accuracy.  Accurate readings result in the same clinical decision when based on the CGM value versus the blood glucose value.  Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ.  Erroneous readings lead to clinical errors.  CGM performance is measured as the sum of accurate readings and benign errors.

Safety was assessed using a five point dermatological scale immediately after sensor removal and again seven days post sensor removal.

Conference Call

Management will host a conference call today starting at 9:00 AM ET to discuss the trial results and other recent developments.  To listen in and/or participate in the call, please dial (877) 300-8521 and reference Echo Therapeutics’ call.  The archived audiocast will be available for fourteen days following the call by visiting the Events section of Echo’s website at www.echotx.com.

About Echo Therapeutics

Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless, continuous glucose monitoring system for use initially in the hospital critical care setting. Significant opportunity also exists for Symphony to be used in the hospital beyond the critical care setting. The Prelude® SkinPrep System, a component of the Symphony CGM System, allows for enhanced skin permeation that will enable extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts, including those regarding Echo’s submission of a CE Mark Technical File for marketing approval in Europe, may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s ongoing studies, including the safety and efficacy of Echo’s Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo’s Symphony CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell the Symphony CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(215) 717-4104
colimpio@echotx.com

Connect With Us:
– Visit our website at www.echotx.com
– Follow us on Twitter at www.twitter.com/echotx
– Join us on Facebook at www.facebook.com/echotx

Tuesday, November 26th, 2013 Uncategorized Comments Off on (ECTE) Announces Positive CE Mark Regulatory Trial Results of Symphony® CGM System

(MBIS) Announces Strategic Investment and Alliance With 3DPrintingIndustry.com

Mediabistro Inc. (Nasdaq:MBIS) today announced that it has made a strategic investment in the 3D printing media platform http://3dprintingindustry.com (3DPI). Mediabistro will not have editorial control of the content of the 3DPI portfolio, which will remain independent, but the two companies will work together to produce Inside 3D Printing trade shows along with the recently announced Maker Summit & Pavilion series that are being produced in major cities worldwide. In addition both companies will soon offer the first online job board for the 3D printing industry, powered by Mediabistro’s proprietary job board software.

“We are pleased to be associated with what we believe to be the most widely read media platform that is fully dedicated to the 3D printing industry and community,” stated Alan M. Meckler, Chairman and CEO of Mediabistro Inc. “Ari Honka and Eetu Kuneinen, the founders of 3DPI, together with Rachel Park, the site’s Editor in Chief, and their superior writing team provide extensive and in-depth daily coverage of all aspects of the growing 3D printing industry worldwide. Also, Mediabistro has the largest coverage of international trade shows for the 3D printing industry combined with coverage of the Maker community. This partnership will enhance marketing dissemination of information and marketing efforts for both companies going forward.”

Ari Honka, Co-founder of 3DPI commented: “As we continue to build 3dprintingindustry.com into the leading multi-media platform for serving the 3D printing sector we are delighted to be working with such a distinguished and experienced partner as Mediabistro. This collaboration offers a strategic fit for several new business areas we are developing at 3DPI — way beyond the investment itself. Both companies have a strong footing in this fast growing industry and we look forward to working closely with Mediabistro to build a truly global presence across a variety of media channels.”

For more information, visit http://inside3dprinting.com.

If your company is interested in sponsoring or exhibiting, contact us at 3dprinting.sponsors@mediabistro.com.

About Mediabistro Inc.

Mediabistro Inc. (Nasdaq: MBIS) is a leading Internet media company that provides services for social media, traditional media, and creative professionals, as well as for innovators in the 3D printing and mobile app industries. Service offerings include an online job boardnews and analysistrade shows and eventsonline and in-person courses, and research products.

All current Mediabistro Inc. press releases can be found online at:
http://corporate.mediabistro.com/corporate/press.html

About 3dprintingindustry.com

3D Printing Industry (3DPI) is a global media company providing dedicated resources for anyone interested in 3D printing — a technology field that is growing quickly in relevance and application across industrial and consumer sectors. The mission of 3DPI is to report on the latest developments in 3D printing to keep our large and growing audience abreast of technology breakthroughs, the latest applications and the opinions of industry insiders. 3DPI provides a compelling blend of articles, blog posts and opinions, as well as videos and images across all platforms through our main website and social media sites. The company is also developing a series of industry leading reports for the market, in collaboration with Econolyst.

Tuesday, November 26th, 2013 Uncategorized Comments Off on (MBIS) Announces Strategic Investment and Alliance With 3DPrintingIndustry.com

(CYTR) to Present at the Sixth Annual LD MICRO “Main Event” Conference

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that President and CEO Steven A. Kriegsman and Vice President of Business Development David J. Haen will present at the 6th Annual LD MICRO “Main Event” Conference on Tuesday, December 3rd, 2013 at 4:00 p.m. Pacific time. The conference is being held at the Luxe Sunset Bel Air Hotel in Los Angeles.

Mr. Kriegsman and Mr. Haen will be available for one-on-one meetings with the investment community on Tuesday, December 3rd. Please contact LD Micro organizers if you would like to arrange a meeting.

Interested parties can access the audio webcast with slide presentation at http://www.cytrx.com/investors/presentations. An archived presentation will be available for 90 days.

About LD MICRO

LD MICRO is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published an annual list of recommended stocks, as well as comprehensive reports on select companies throughout the year. The firm also hosts the LD MICRO Micro-Cap Growth Conference for investors in December of each year. This year’s conference will feature presentations by over 225 publicly-traded companies and is expected to attract more than 1,000 attendees.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and is initiating a Phase 2 clinical trial for AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Tuesday, November 26th, 2013 Uncategorized Comments Off on (CYTR) to Present at the Sixth Annual LD MICRO “Main Event” Conference

(HTBX) Completes HS-410 Manufacturing For Phase 1/2 Bladder Cancer Trial Start

Company Remains on Track to Commence Patient Enrollment in Phase 1/2 Trial Before Year End

Company Remains on Track to Commence Patient Enrollment in Phase 1/2 Trial Before Year End

CHAPEL HILL, NC–(Marketwired – Nov 25, 2013) – Heat Biologics, Inc. (“Heat Biologics,” “Heat”) (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that the Company has successfully completed the manufacture of the first GMP-grade batch of its HS-410 investigational drug, a fully-allogeneic, “off-the-shelf” live-cell cancer immunotherapy, for its planned Phase 1/2 bladder cancer trial. Heat remains on track to commence patient enrollment before year-end.

Heat Biologics’ allogeneic approach means that its live cell-based vaccines can be mass-produced and stockpiled for use on all patients, even before patients are identified and enrolled. Heat’s drug is capable of being produced and administered at a fraction of the cost of autologous or “personalized” therapies. Unlike the current autologous cancer immunotherapies, Heat Biologics’ proprietary, patented technology requires no invasive procedures to remove and re-deliver tumor or immune cells and therefore there are far fewer logistical hurdles in its production and delivery.

“The successful manufacture and delivery of our first clinical trial-grade drug for use in our upcoming Phase 1/2 bladder cancer study represents an important milestone for Heat and we believe clearly demonstrates the efficiency and effectiveness of our manufacturing efforts,” said Jeff Wolf, CEO of Heat Biologics. “This is especially exciting as it showcases a true differentiation of Heat’s proprietary technology and manufacturing platform.”

Heat’s proprietary Immune Pan Antigen Cytotoxic Therapy (“ImPACT”) reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells, which is designed to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient’s cancer. Heat’s “ImPACT” technology holds promise for treating a wide variety of different cancers.

According to the American Cancer Society, in 2012, there were 73,000 new cases of bladder cancer reported and 15,000 deaths from the disease in the U.S. alone. More than 500,000 people in the U.S. have been treated for bladder cancer. Importantly, the FDA has not approved any new drugs to treat bladder cancer in more than 25 years. Heat’s HS-410 represents a viable opportunity to address a significant unmet medical need.

About HS-410 for the Treatment of Advanced Bladder Cancer

HS-410 is a biologic product candidate which consists of a bladder cancer cell line that has been genetically modified using Heat’s ImPACT technology platform to secrete a wide range of bladder cancer antigens bound to a gp96 adjuvant and is designed to activate a T-cell mediated pan-antigen immune response against the patient’s bladder cancer.

On October 1, 2013, the Company submitted an IND to the FDA to initiate a Phase 1/2 for use of its HS-410 to prevent the recurrence of bladder cancer. The Company expects to begin enrolling patients in this study by the end of December 2013.

The Phase 1/2 trial is designed to examine safety, tolerability, immune response and preliminary clinical activity of HS-410 in patients with high risk, superficial bladder cancer who have completed surgical resection and intravesical bacillus Calmet-Guerin (BCG) immunotherapy instillations. The Company anticipates including approximately 8-10 clinical sites.

About Heat Biologics, Inc.
Heat Biologics, Inc. (www.heatbio.com) is a clinical-stage biopharmaceutical company focused on developing its novel, “off-the-shelf” ImPACT therapeutic vaccines to combat a wide range of cancers. Our ImPACT Therapy is designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to “pump out” a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called “gp96” to educate and activate a cancer patient’s immune system to recognize and kill cancerous cells. Heat’s HS-110 will be entering Phase 2 trials against non-small cell lung cancer and its HS-410 will be entering Phase 1/2 clinical trials against bladder cancer.

Forward Looking Statements
This press release includes forward-looking statements on our current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the manufacturing efficiency and effectiveness and the potential for Heat’s ImPACT Therapy. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability for Heat’s ImPACT Therapy to perform as designed and Heat’s ability to commence enrollment and complete clinical trials as anticipated. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

Heat Biologics, Inc. Contact Information
Matthew Czajkowski
Chief Financial Officer
(919) 240 7133
Email Contact

Jenene Thomas
Investor Relations and Corporate Communications Advisor
Jenene Thomas Communications, LLC
(908) 938-1475
Email Contact

Monday, November 25th, 2013 Uncategorized Comments Off on (HTBX) Completes HS-410 Manufacturing For Phase 1/2 Bladder Cancer Trial Start

(IDIX) to Present at Two Upcoming Healthcare Conferences

CAMBRIDGE, Mass., Nov. 25, 2013  — Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), announced today that Idenix management will participate in a fireside chat discussion at the 2013 Deutsche Bank BioFEST on Monday, December 2, 2013, at 10:45 a.m. ET at the Four Seasons Hotel in Boston, MA. Management will also present a corporate overview at the Oppenheimer 24th Annual Healthcare Conference on Tuesday, December 10, 2013, at 4:30 p.m. ET at the Crowne Plaza Hotel in New York, NY.

The live and archived webcasts of the company presentations can be accessed under “Events and Presentations” in the Idenix Investor Center at www.idenix.com. Please log in approximately 5-10 minutes before each event to ensure a timely connection. The archived replay will be available on the Idenix website for two weeks following the conferences.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix’s current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

CONTACT: Idenix Pharmaceuticals Contact:
         Teri Dahlman
         (617) 995-9807
Monday, November 25th, 2013 Uncategorized Comments Off on (IDIX) to Present at Two Upcoming Healthcare Conferences

(TGTX) Initiates First Combination Clinical Trial of TG-1101 and TGR-1202

  • Combination trial led by Susan O’Brien, MD and Nathan Fowler, MD from the MD Anderson Cancer Center in Houston, Texas
  • Nodal responses observed at 800mg once per day; Company initiates first expansion cohort of TGR-1202 as a single agent while dose escalation continues

NEW YORK, Nov. 25, 2013  — TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative, clinical-stage biopharmaceutical company today announced that it has initiated a multi-center, Phase I trial to evaluate the safety and efficacy of the combination of TG-1101 (ublituximab) and TGR-1202 for patients with relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL). This will be the first clinical trial evaluating the combination of TG-1101, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s novel, once per day, PI3K Delta inhibitor. In this study, dosing of TGR-1202 will commence at 800mg once per day (or QD) with dose escalation proceeding in a 3+3 design.

The trial, entitled “A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TG-1101 (Ublituximab), a novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination with TGR-1202, a Novel PI3k Delta Inhibitor, in Patients with B-cell Malignancies,” will enroll CLL and NHL patients whose disease is relapsed from or refractory to prior therapies, including prior anti-CD20 monoclonal antibodies, PI3K Delta inhibitors, and/or BTK inhibitors. The MD Anderson Cancer Center will be the lead center for the trial. Susan O’Brien, MD, Professor in the Department of Leukemia, will be the Study Chair for the CLL patient group, and Nathan Fowler, MD, Assistant Professor and Co-Director of Clinical Research in the Department of Lymphoma, will be the Study Chair for the NHL patient group.

In addition, TG Therapeutics announced today that it has opened its first expansion cohort in its ongoing single agent Phase 1 dose escalation study of TGR-1202. The expansion cohort will enroll additional patients at the 800mg QD dose level. As a maximum tolerated dose has not been reached, dose escalation continues in this study. To date, the Company has not observed any TGR-1202 drug-related liver toxicity. At the upcoming American Society of Hematology Meeting (ASH) in December 2013, the Company intends to present detailed pharmacokinetic and safety data for all patients in the ongoing single agent study of TGR-1202 through the 1200mg QD cohort as well as efficacy data through the 800mg QD dose escalation cohort (Abstract 4373 which can be found at https://ash.confex.com/ash/2013/webprogram/Paper61825.html).

“With the confirmation of activity of TGR-1202, we are one step closer to fulfilling our vision of bringing highly active, less toxic, non-chemotherapy based combination treatment options to patients with B-cell malignancies,” stated Michael S. Weiss, Executive Chairman and Interim CEO, who continued, “The commencement of this combination study today represents a major milestone for the Company and is the beginning of what we expect to be a robust combination clinical program, which will include our much anticipated combination of TG-1101 with ibrutinib. We are very excited to have MD Anderson as our lead center and to be working with Dr. O’Brien and Dr. Fowler, as co-lead investigators for this important clinical trial.”

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor, jointly with Rhizen Pharmaceuticals S A. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that pre-clinical and early clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following completion of the current phase 1 study; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX-G

CONTACT: Jenna Bosco
         Director- Investor Relations
         TG Therapeutics, Inc.
         Telephone: 212.554.4484
         Email: ir@tgtxinc.com
Monday, November 25th, 2013 Uncategorized Comments Off on (TGTX) Initiates First Combination Clinical Trial of TG-1101 and TGR-1202

(OREX) Announces Successful Interim Analysis of Contrave Light Study

Company will Resubmit the Contrave NDA in the Next Few Weeks – Potential Approval by June 2014

SAN DIEGO, Nov. 25, 2013 — Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced successful results of the interim analysis of the Light Study. Based on these results, the Company will resubmit the Contrave® New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the next few weeks with potential approval by June 2014.

“The interim analysis of the Light Study clearly achieved the goal set by the FDA,” said Michael Narachi, CEO of Orexigen.  “The resubmission will contain an unprecedented amount of cardiovascular outcomes data for an obesity therapeutic, and we are confident these data will support a favorable benefit:risk assessment for Contrave.”

The FDA previously agreed that if the interim analysis meets the specified criteria to exclude cardiovascular risk, Contrave could be approved. The pre-specified criteria for the interim analysis is to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as compared to placebo. In addition to meeting the pre-specified criteria for excluding cardiovascular risk, no new safety signals were observed.

“Takeda is excited about this major milestone for Contrave,” said Doug Cole, President of Takeda Pharmaceuticals U.S.A., Inc., Orexigen’s partner for Contrave in North America. “Takeda is pleased to partner with Orexigen to develop a therapeutic option that has the potential to help patients achieve meaningful and sustained weight loss over time.”

Conference Call This Morning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the interim analysis results. The live call may be accessed by phone by calling (888) 895-5479 (domestic) or (847) 619-6250 (international), participant code 36202424. The webcast can be accessed live on the Investor Relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.

About the Light Study

The Contrave Light Study is a double‐blind, placebo‐controlled cardiovascular outcomes trial that randomized approximately 8,900 patients.  The primary objective of the Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA at approximately 260 clinical sites in the United States, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.

By agreement with the FDA, the independent Data Monitoring Committee’s summary report of the Light Study interim analysis will form the basis of the resubmission of the NDA, and the complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the NDA resubmission filing, will be supplied to the FDA during its review within 60 days of the NDA resubmission.

Following potential approval in June 2014, the Light Study will continue, blinded, until the trial is completed.

About Contrave
Contrave (naltrexone sustained release (SR)/bupropion SR) is an investigational medication being evaluated for weight loss. Prior to initiation of the Light Study, Contrave was studied in clinical trials enrolling more than 4,500 people. Contrave has been shown to help people lose weight and keep it off for up to one year. In previous clinical trials, 53 percent of study participants taking Contrave and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Many patients saw noticeable improvements in cholesterol levels, and blood sugar control, as well as smaller waistlines. Those who combined Contrave with diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will make patients lose weight.

Contrave was generally well tolerated in earlier clinical trials. In the Contrave Phase 3 clinical development program, the most frequent adverse events on Contrave were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity and did not last long.

Orexigen has licensed North American Contrave rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories. In October 2013, Orexigen submitted a Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA).

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company’s lead product candidate is Contrave, which has completed Phase 3 clinical trials and for which a New Drug Application had been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The Company’s other product candidate, Empatic, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.

Forward‐Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward‐looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward‐looking statements. These statements are based on the Company’s current beliefs and expectations. These forward‐looking statements include statements regarding: the timing of resubmission and potential approval of the NDA for Contrave; the benefit risk profile for Contrave; Orexigen’s plans to seek a commercialization partner in territories outside of North America; and the timing of the submission of the CSR for the interim analysis. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: delays in the resubmission of the Contrave NDA; the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the CSR for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; the potential for the FDA to not approve Contrave even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis would later be deemed to jeopardize the integrity of the Light Study potentially resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study; the potential for early termination of Orexigen’s North American collaboration agreement with Takeda Pharmaceutical Company Limited; the results from the interim analysis may not sufficient to satisfy or respond to the Day 120 List of Questions from the EMA or any other data requirements of the EMA in connection with the review of the MAA; even if the NDA is approved by the FDA, the final results of the Light Study may not support continued approval of Contrave; the therapeutic and commercial value of Contrave; Orexigen’s ability to maintain sufficient capital to fund its operations through potential approval of Contrave in 2014; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‐looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Quarterly Report on Form 10‐Q filed with the Securities and Exchange Commission November 12, 2013 and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investor Relations.” All forward‐looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Orexigen Contact: Media Contact:
McDavid Stilwell Denise Powell
VP, Corporate Communications and Business Development BrewLife
(858) 875-8629 (510) 703-9491
Monday, November 25th, 2013 Uncategorized Comments Off on (OREX) Announces Successful Interim Analysis of Contrave Light Study

(AEZS) Announces Closing of US$15.1 Million Public Offering of Common Shares and Warrants

QUÉBEC CITY, Nov. 25, 2013 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced the closing of its previously announced public offering of 13.1 million units (the “Offering”) generating net proceeds of approximately US$13.7 million, with each unit consisting of one common share and one whole warrant to purchase one common share, at a purchase price of US$1.15 per unit. Each warrant is exercisable for a period of five years at an exercise price of US$1.60 per share. Canaccord Genuity Inc. acted as the sole book-running manager, and Maxim Group LLC act as co-manager for the Offering.

The Company intends to use the net proceeds from the Offering to continue to fund its ongoing drug development activities, primarily for the advancement of its zoptarelin doxorubicin (AEZS-108) program, secondly for its macimorelin acetate (AEZS-130) program, including the preparation of its commercial launch, as well as for the potential addition of commercialized products to the Company’s pipeline, future negative cash flow, general corporate purposes and working capital.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology. The Company’s pipeline encompasses compounds from drug discovery to regulatory approval. For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

SOURCE Aeterna Zentaris Inc.

 

Investor Relations
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com

Media Relations
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com

Monday, November 25th, 2013 Uncategorized Comments Off on (AEZS) Announces Closing of US$15.1 Million Public Offering of Common Shares and Warrants

(IDRA) to Present at the 25th Annual Piper Jaffray Healthcare Conference

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today announced that Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera will present at the 25th Annual Piper Jaffray Healthcare Conference on Wednesday, December 4, 2013 at 3:00 p.m. EST at the New York Palace Hotel in New York City.

A live audio webcast of the presentation will be available in the Investors and Media section of Idera’s website at www.iderapharma.com or at the link http://www.media-server.com/m/p/c8zsyhqf. An archived version will also be available on the Company’s website after the event for 90 days.

About Idera Pharmaceuticals, Inc.

Idera’s technology platform involves creating novel synthetic RNA- and DNA-based compounds to modulate immune responses. Idera has applied this platform to develop proprietary Toll-like receptor (TLR) antagonists as immunomodulatory drug candidates. Toll-like receptor antagonists block the over-activation of immune factors which can cause a range of pathological effects. Idera is conducting clinical development of TLR antagonists in autoimmune and inflammatory diseases, and preclinical development of their use in certain genetically defined forms of B-cell lymphoma. More information on Idera is available at www.iderapharma.com.

Monday, November 25th, 2013 Uncategorized Comments Off on (IDRA) to Present at the 25th Annual Piper Jaffray Healthcare Conference

(CTHR) Forever Brilliant® Moissanite Collection Now Available at Helzberg.com

Partnership Targeted to Provide Sales Opportunity and Increase Awareness for The World’s Most Brilliant Gem

Charles & Colvard, Ltd. (NASDAQ:CTHR), the exclusive global supplier of the Forever Brilliant® moissanite gem, has entered into a distribution agreement with Helzberg Diamonds, a Berkshire Hathaway Company and one of the oldest and largest retail and online jewelry stores, to directly supply Forever Brilliant® moissanite fine jewelry in 14-karat gold to the retailer’s e-commerce site.

“We are excited to announce our partnership with one of the largest U.S. jewelry retailers, Helzberg Diamonds, especially as Charles & Colvard’s continues to expand channel offerings and increase consumer awareness of moissanite in time for the all-important holiday season,” said Randy N. McCullough, CEO at Charles & Colvard. “For more than 90 years, Helzberg has provided customers with superior service and high-quality jewelry, and the availability of Forever Brilliant® moissanite in their online store is a testament to the growing excitement for our proprietary gemstone.”

“We are very pleased to bring Forever Brilliant® moissanite jewelry to Helzberg’s online customers, said Steve Larkin, COO of Charles & Colvard. This partnership between Charles & Colvard and Helzberg is designed to increase consumer access to moissanite. We believe this is the perfect opportunity to build awareness of our finest brand of moissanite, Forever Brilliant®. We look forward to bringing our proprietary Forever Brilliant gem to the many Helzberg consumers and satisfying their demand for beautiful 14-karat gold Forever Brilliant® moissanite stud earrings, solitaire rings, bridal, and fashion fine jewelry through Helzberg’s online store.”

More information about the entire Charles & Colvard moissanite line is available at www.charlesandcolvard.com.

About Helzberg Diamonds:

Helzberg Diamonds was founded over 90 years ago, and since day one we’ve dedicated ourselves to delighting our customers with superior service and high-quality jewelry. That’s because we understand how special it is to buy fine jewelry – and we want you to treasure the experience for years to come. For more information, please visit www.helzberg.com.

About Charles & Colvard:

Charles & Colvard, Ltd., based in the Research Triangle Park area of North Carolina, is the global sole source of moissanite, a unique, near-colorless created gemstone that is distinct from other gemstones and jewels based on its exceptional fire, brilliance, luster, durability, and rarity. Charles & Colvard Created Moissanite® and Forever Brilliant® are currently incorporated into fine jewelry sold through domestic and international retailers and other sales channels. Charles & Colvard, Ltd.’s common stock is listed on the NASDAQ Global Select Market under the symbol “CTHR.” For more information, please visit www.charlesandcolvard.com.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements expressing expectations regarding our future and projections relating to products, sales, revenues, and earnings are typical of such statements and are made under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations, and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “continue,” and similar words, although some forward-looking statements are expressed differently.

All forward-looking statements are subject to the risks and uncertainties inherent in predicting the future. You should be aware that although the forward-looking statements included herein represent management’s current judgment and expectations, our actual results may differ materially from those projected, stated, or implied in these forward-looking statements as a result of many factors including, but not limited to, our dependence on consumer acceptance and growth of sales of our products resulting from our strategic initiatives; dependence on a limited number of customers; our ability to fulfill orders on a timely basis; the financial condition of our major customers; dependence on Cree, Inc. as the sole current supplier of the raw material; our current wholesale customers’ potential perception of us as a competitor in the finished jewelry business; intense competition in the worldwide jewelry industry; general economic and market conditions, including the current economic environment; risks of conducting business in foreign countries; the pricing of precious metals, which is beyond our control; the potential impact of seasonality on our business; our ability to protect our intellectual property; the risk of a failure of our information technology infrastructure to protect confidential information and prevent security breaches; possible adverse effects of governmental regulation and oversight; and the failure to evaluate and integrate strategic opportunities, in addition to the other risks and uncertainties described in our filings with the Securities and Exchange Commission, or the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2012 and subsequent reports filed with the SEC. Forward-looking statements speak only as of the date they are made. We undertake no obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur except as required by the federal securities laws, and you are urged to review and consider disclosures that we make in the reports that we file with the SEC that discuss other factors relevant to our business.

Friday, November 22nd, 2013 Uncategorized Comments Off on (CTHR) Forever Brilliant® Moissanite Collection Now Available at Helzberg.com

(LFVN) CSO David Phelps Sees “Extraordinary Growth Potential”

SALT LAKE CITY, Nov. 22, 2013 — LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically-validated products, introduced David Phelps as its first-ever Chief Sales Officer on Tuesday, and already Phelps is speaking out.

“LifeVantage has extraordinary growth potential,” Phelps said. “The current product line has fueled impressive growth since the company entered into network marketing in 2009, but I believe that is just our taking-off point.”

Phelps continued, “We’re expanding our U.S. market, preparing to launch our flagship product, Protandim®, the Nrf2 Synergizer® patented dietary supplement, in a number of major new markets worldwide and gearing up to announce exciting new products, all in keeping with our commitment to offer unique science-based formulations for healthy living.”

“Our approximately 70,000 independent distributors have their eyes on a prize,” added Phelps, “and that’s making LifeVantage a billion-dollar company. They know we have the products and sales know-how to do that. I just spent 24 hours with the company’s top 19 global distributors at a summit in Utah. These are some of the most determined, passionate, experienced and insightful network marketers I have ever met. Their conviction and energy, combined with the work of the smart, hard-charging LifeVantage management team, enhances our growth potential.” Phelps also noted, “I am truly impressed with the entire leadership team’s unity in creating the next wave of LifeVantage momentum.”

A globally recognized expert in network marketing, Phelps’s experience spans North America, Europe, Latin America and nearly every major market in Asia. He has worked at Synergy Worldwide, FFi, Jeunesse Global, MonaVie and Organo Gold, applying his skills in sales, marketing, international expansion, business development, training and nearly every facet of distributor-facing development work. Phelps received his Juris Doctorate from Brigham Young University.

Douglas C. Robinson, LifeVantage President and Chief Executive Officer, noted, “Like the rest of the LifeVantage management team, Dave is driven by two essential concepts: Distributors are the company’s most important assets, and leadership development is the heart of our network marketing success. LifeVantage is ready to surge to new heights, and we are excited to have Dave Phelps join the team that will help take us there.”

About LifeVantage Corporation

LifeVantage Corporation (Nasdaq:LFVN), a leader in Nrf2 science and the maker of Protandim®, the Nrf2 Synergizer® patented dietary supplement, TrueScience® Anti-Aging Cream and LifeVantage® Canine Health, is a science-based network marketing company. LifeVantage is dedicated to visionary science that looks to transform wellness and anti-aging internally and externally with products that dramatically reduce oxidative stress at the cellular level. The Company was founded in 2003 and is headquartered in Salt Lake City, Utah. More information is available at www.LifeVantage.com.

FORWARD LOOKING STATEMENTS

This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words and expressions reflecting optimism and satisfaction with current prospects, as well as words such as “believe,” “anticipates,” “look forward to,” “should” and variations thereof, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements we make regarding the Company’s growth potential are not guarantees of performance and the Company’s actual results could differ materially from those contained in such statements. These forward-looking statements are based on the Company’s current expectations and beliefs concerning future events affecting the Company and involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein. These risks and uncertainties include, among others the risk factors discussed in greater detail in the Company’s Annual Report on Form 10-K and its Quarterly Report on Form 10-Q under the caption “Risk Factors,” and in other documents filed by the Company from time to time with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this document, except as required by law.

CONTACT: Public Relations Contact:
         John Genna (801) 432-9172
         Vice President of Marketing & Communications

         Investor Relations Contact:
         Cindy England (801) 432-9036
         Director of Investor Relations
         or
         John Mills (310) 954-1105
         Senior Managing Director, ICR, LLC
Friday, November 22nd, 2013 Uncategorized Comments Off on (LFVN) CSO David Phelps Sees “Extraordinary Growth Potential”

(BIIB) CHMP Determines Dimethyl Fumarate in TECFIDERA® New Active Substance in EU

Today Biogen Idec (NASDAQ: BIIB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in TECFIDERA qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for TECFIDERA in the European Union (EU).

The NAS determination follows a positive opinion by the CHMP in March 2013 recommending marketing authorization in the EU for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP’s determination will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the EU.

“We are heartened by the CHMP’s NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe. We are ready to introduce TECFIDERA in EU countries shortly after anticipated approval,” said Douglas Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “This designation validates the tremendous investment we have made in TECFIDERA and enables us to invest in future research focused on reversing the course of MS and hopefully one day finding a cure for patients.”

If approved, TECFIDERA will mark the fourth therapy that Biogen Idec offers to people living with MS in the European Union.

About TECFIDERA®

TECFIDERA is an oral therapy for relapsing forms of MS, including RRMS, the most common form of MS. TECFIDERA is currently approved in the United States, Canada and Australia, and is under review by regulatory authorities in the European Union.

TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions, while demonstrating a favorable safety and tolerability profile. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and GI events. Other side effects included a decrease in mean lymphocyte counts during the first year of treatment, which then remained stable. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program, which includes an ongoing long-term extension study.

It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Safe Harbor

This press release contains forward-looking statements, including statements about the anticipated approval of TECFIDERA by the EC. These statements may be identified by words such as “believe,” “expect,” “anticipate,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including the risk that the EC may fail to approve or may delay approval of TECFIDERA or may not follow the recommendation of the CHMP, the risk that we encounter other unexpected hurdles or difficulties in launching in EU countries, and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Friday, November 22nd, 2013 Uncategorized Comments Off on (BIIB) CHMP Determines Dimethyl Fumarate in TECFIDERA® New Active Substance in EU